Investigating the effect of sexual health counseling with a problem-solving approach Online and face-to-face on the sexual satisfaction of women with polycystic ovary syndrome
Comparing the effectiveness of sexual health counseling with problem solving approaches with online and face-to-face on sexual satisfaction of women with polycystic ovary syndrome
Design
This intervention research (consultation with a problem solving approach), in a randomized semi-experimental way without blinding, on 56 women with polycystic ovary syndrome, who were divided into two groups in person (28 people) and online ( 28 people) will be divided. Sampling in the centers will be targeted non-random sampling.
Settings and conduct
Diabetes Research Center and Baqaei Pour Clinic of Yazd, sampling, random allocation, counseling intervention by the researcher
Participants/Inclusion and exclusion criteria
Inclusion
Women with polycystic ovary syndrome according to the Rotterdam criteria and doctor's diagnosis
Iranian and resident of Yazd city
At least literate in reading and writing and speaking Persian language
Completion of informed consent to participate in the research
Ages 18-45 years
Having Smart mobile phone
Desire to install the messenger program
Married
To cross At least one year from the start of marriage
Exclusion
Using drugs that affect sexual performance (for example: blood lipid-lowering drugs, cimetidine, digoxin, progesterone, antidepressants, etc.)
Consumption of alcohol and psychoactive substances according to the patient
Simultaneous participation in similar studies
People with known mental problems under medical treatment (such as depression, etc.)
pregnancy
Women who have recently given birth and have children less than 6 months old
The occurrence of major stress in the last 6 months, including the loss of loved ones
Intervention groups
Counseling with a problem-solving approach is held in six two-hour sessions in one group in person and the other online (in Messenger program) once a week.
Main outcome variables
Change in mean sexual satisfaction scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230302057590N1
Registration date:2023-03-25, 1402/01/05
Registration timing:prospective
Last update:2023-03-25, 1402/01/05
Update count:0
Registration date
2023-03-25, 1402/01/05
Registrant information
Name
Fatemeh Dehghanimohammadabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3836 3583
Email address
f.dehghanimohammadabadi@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-22, 1402/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of sexual health counseling with a problem-solving approach Online and face-to-face on the sexual satisfaction of women with polycystic ovary syndrome
Public title
Investigating sexual health counseling with a problem-solving approach with online and face-to-face on sexual satisfaction of women with polycystic ovary syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovary syndrome according to the Rotterdam criteria and doctor's diagnosis
Iranian and resident of Yazd city
At least literate in reading and writing and speaking Persian language
Completion of informed consent to participate in the research
Ages 18-45 years
Having Smart mobile phone
Desire to install the messenger program
Married
To cross At least one year from the start of marriage
Exclusion criteria:
Using drugs that affect sexual performance (for example: blood lipid-lowering drugs, cimetidine, digoxin, progesterone, antidepressants, etc.)
Consumption of alcohol and psychoactive substances according to the patient
Simultaneous participation in similar studies
People with known mental problems under medical treatment (such as depression, etc.)
pregnancy
Women who have recently given birth and have children less than 6 months old
The occurrence of major stress in the last 6 months, including the loss of loved ones
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible women are selected by purposive sampling and each woman is assigned a code from 1 to 56 for random assignment. According to the output of the software, the random numbers prepared by the statistician with the online software by randomization method on the web using the site http://www.graphpad.com/quickcalcs/index.cfm are 28 numbers in group A and 28 numbers In group B, they are randomly assigned, and neither the women nor the researcher knows the name of the group to which each woman will be assigned. The numbers of each group are written on a piece of paper and placed inside a sealed envelope, then a collaboration outside the research team is asked to use a simple randomization method to determine which groups are face-to-face and which are online.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
8916189165
Approval date
2023-01-24, 1401/11/04
Ethics committee reference number
IR.SSU.REC.1401.084
Health conditions studied
1
Description of health condition studied
Counseling on sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sexual satisfaction score in Larson's sexual satisfaction questionnaire
Timepoint
Before the start of the intervention, immediately after the end of the intervention and one month after the end of the intervention
Method of measurement
Larson sexual satisfaction questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention in the face-to-face group is held in the form of 6 2-hour sessions at the diabetes clinic once a week by a senior student of counseling in midwifery, under the supervision of the research team. Larson's sexual satisfaction questionnaire will be completed three times before, immediately after and one month after the end of the intervention. A reminder SMS will be sent to all people the day before the sessions. will be The content of the sessions includes the undeniable fact of the problem in life, talking about polycystic ovary syndrome, teaching the anatomy and physiology of the reproductive system, creating creative solutions, evaluating options and choosing the best solution, implementing and reviewing solutions, evaluating the implemented method, Summarizing and reviewing meetings. At the end of each session, the important topics are summarized and the women are asked to do their homework until the next session. In each meeting, the contents of the previous meetings will be reviewed and homework will be checked.
Category
Behavior
2
Description
The second intervention group: intervention in the online group in the form of 6 sessions of 2 hours in the space of the messenger program in the form of PowerPoint and Voice in a group once a week by a senior student of counseling in midwifery, under the supervision of the research team. Larson's sexual satisfaction questionnaire will be completed three times before, immediately after and one month after the end of the intervention. A reminder SMS will be sent to all people the day before the meeting. The content of the sessions includes the undeniable fact of the problem in life, talking about polycystic ovary syndrome, teaching the anatomy and physiology of the reproductive system, creating creative solutions, evaluating options and choosing the best solution, implementing and reviewing solutions, evaluating the implemented method, Summarizing and reviewing meetings. At the end of each session, the important topics are summarized and the women are asked to do their homework until the next session. In each meeting, the contents of the previous meetings will be reviewed and homework will be checked.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqaipour Clinic, Shahid Sadoughi Hospital, Yazd
Full name of responsible person
Behnaz Enjezab
Street address
Next To The Main Door Of Shahid Sadoughi Hospital, Math Square, Safaiye
City
Yazd
Province
Yazd
Postal code
8915887857
Phone
+98 35 3822 9105
Email
enjezabbehnaz@yahoo.com
2
Recruitment center
Name of recruitment center
Diabetes clinic
Full name of responsible person
Behnaz Enjezab
Street address
Art Hall Alley, Bahnar Square, Shahid Sadoughi Blvd
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0228
Fax
+98 35 3728 0216
Email
enjezabbehnaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Amirhoshang Mehrparvar
Street address
Yazd, Bahnar Square, Central Organization of Yazd University of Medical Sciences
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Fax
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali Ave, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
009838241751
Email
enjezabbehnaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali Ave, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
009838241751
Email
enjezabbehnaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behnaz Enjezab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Bouali Ave, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877443
Phone
009838241751
Email
enjezabbehnaz@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of study participants can be shared after un identifying.
When the data will become available and for how long
After printing the results.
To whom data/document is available
The data will be accessible to researchers working in scientific and academic institutions.
Under which criteria data/document could be used
Scientific use.
From where data/document is obtainable
enjezabbehnaz@yahoo.com
What processes are involved for a request to access data/document
At least one week after receiving the requester's email.